At Imperial College Healthcare NHS Trust you can achieve extraordinary things with extraordinary people. You'll be working with leading clinicians pushing boundaries in patient care. Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You'll get an experience like no other and will fast forward your career.

Benefits include opportunities for career development, flexible working and wellbeing, plus a staff recognition scheme. Also, take advantage of optional benefits including the cycle to work and car lease schemes, season ticket loan or membership options for onsite leisure facilities.

The Clinical Haematology Department based at Hammersmith Hospital continues to expand and develop innovative treatment pathways to drive forward the high standards of care that we aspire to deliver for all our patients. This includes the John Goldman Centre for Cellular Therapy that provides highly specialist clinical, technical and scientific services for patients undergoing stem cell transplantation and immunotherapy. In addition to supporting the routine clinical stem cell transplant programme, the JGCCT also collaborates on the development and manufacture of new cellular therapies. The laboratory is located in a purpose built facility licensed by the HTA and accredited by JACIE. It additionally holds IMP Specials license issued by the MHRA.

Main duties of the job

You will work closely with the Head of Quality in maintaining compliance with all relevant licensing and accreditation standards for the site and improve service delivery to users by working in partnership with all stakeholders.

Day to day involvement with colleagues of varying levels of seniority in many departments and centres regarding all elements of the Quality system including adverse events/reactions investigations, audits, non-conformities, change controls, validations, out of specifications/ out of trend investigations, complaints & recall.

Deputising for the Head of Quality and assist the cross function teams when required.

Producing reports and leading quality review meetings with department managers as well as facilitating meetings to investigate events and determine root cause.

The post holder will organise and manage the workload for the quality function, maintain and keep up to date with standards of Good Manufacturing Practice. Participate in the training and development of permanent and temporary staff working in the unit. Support the maintenance and management of the programmes JACIE accreditation.

The post holder will additionally be involved in undertaking risk assessments, COSHH assessments and the GAP assessment of new process / product introduction.

About us

At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care.

Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You'll get an experience like no other and will fast forward your career.

Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to Work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.

We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part time or job share. Please talk to us at interview. .

Job description

Job responsibilities

The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required.

For both overviewsplease view the Job Description attachment with the job advert.

Person Specification

Education/Qualifications

Essential

• oEducated to BSc level in Biomedical Science degree or equivalent

Desirable

• oQuality Management qualification

Experience

Essential

• oExperience working to Good Manufacturing Practice (Industry or NHS)
• oExperienced at problem solving - deviations, root cause analysis, corrective and preventive actions
• oExperience in documentation, record management and data integrity
• oExperience in conducting and reporting internal audits

Desirable

• oExperience in managing an electronic quality management system e.g. Q-Pulse
• oExperience working in MHRA licensed facility
• oExperience with Advanced therapy medicinal products (ATMPs)
• oExperience in technology transfer

Skills/Knowledge/ Abilities

Essential

• oGood understanding of JACIE & HTA standards and their application.
• oUnderstanding EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines and application
• oKnowledge of ICH Guidelines.

Desirable

• oKnowledge of European Pharmaceutical Directives
• oManagement of quality and GMP at approved vendors and contractors
• oValidation life cycle including computer systems

Employer details

Employer name

Imperial College Healthcare NHS Trust

Address

Hammersmith Hospital

Du Cane Road

London

W12 0HS

Any attachments will be accessible after you click to apply.

290-SCCS-1600